Modafinil, Sleep, and Cognition in Cocaine Dependence - Full Text View

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00582491

Purpose

Subjects participating in this protocol will participate in three phases: 1) pre-admission, 2) inpatient admission, and 3) follow-up. Pre-admission involves screening (detailed in inclusion/exclusion criteria section) and one week of outpatient sleep and activity monitoring. Inpatient admission is 16 consecutive nights on the Clinical Neuroscience Research Unit and involves subjective and objective tests of sleep, sleepiness, attention, and learning. During inpatient admission subjects will take modafinil or placebo. For follow-up, subjects will return to the CNRU for one night and again participate in objective tests of sleep, sleepiness, attention, and learning. We hypothesize that modafinil will decrease subject and objective measures of sleepiness and will promote attention and learning in cocaine dependent persons.

Condition	Intervention
Cocaine Dependence Substance-Induced Sleep Disorder Substance-Induced Cognitive Disorder	Drug: Modafinil Drug: Placebo

MedlinePlus related topics: Sleep Disorders

Drug Information available for: Modafinil 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	Modafinil, Sleep, and Cognition in Cocaine Dependence

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Effect of modafinil versus placebo on daytime sleepiness [ Time Frame: 16 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effect of modafinil versus placebo on cognitive performance [ Time Frame: 16 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	August 2006
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental Modafinil 400mg PO QDaily	Drug: Modafinil Modafinil 400mg PO QDaily for 16 days
II: Placebo Comparator Placebo arm	Drug: Placebo Placebo PO QDaily for 16 days

Detailed Description:

A relatively new treatment for the excessive daytime sleepiness (EDS) associated with inadequate sleep is the drug modafinil. Modafinil decreases subjective reports and objective measures of daytime sleepiness under conditions of sleep restriction, while enhancing cognitive performance. At the same time, sleep quality does not appear to be affected significantly. Interestingly, recent clinical trials in cocaine-dependent populations suggest that modafinil reduces the relapse to cocaine use, by unknown mechanisms.

We propose to employ both subjective and objective measures of nocturnal sleep and daytime sleepiness, as well as measures of general cognitive performance and sleep-dependent memory consolidation, to explore potential mechanistic relationships between cocaine abstinence, EDS, and modafinil's efficacy in preventing cocaine relapse.

The following specific aims are proposed:

Specific Aim 1: To establish whether objective measures of poor nocturnal sleep (e.g., reduced total sleep time and sleep efficiency) that progressively characterize periods of sustained cocaine abstinence are also associated with objective evidence of excessive daytime sleepiness (EDS).

Specific Aim 2: To establish the ability of modafinil to reverse the excessive daytime sleepiness (EDS) and deficits in cognitive performance that characterize cocaine abstinence.

Specific Aim 3: To conduct a pilot study to determine whether the observed abnormalities in objective sleep, EDS, and/or cognitive function predict relapse to cocaine use and/or whether successful abstinence from cocaine is associated with normalization of the same.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female individuals, ages 18-65, meeting current DSM-IV criteria for cocaine dependence. Documented positive urine toxicology screen for cocaine at intake and regular 3 times more weekly use of cocaine.
Subject has voluntarily given informed consent and signed the informed consent document(s).
Able to read English and complete study evaluations.

Exclusion Criteria:

Use of prescription medication in the past 6 months indicating a medical or psychiatric condition that in the opinion of the PI would interfere with study participation (e.g. hypertension, severe renal or hepatic disease, HIV, primary psychotic disorder, primary mood disorder, primary sleep disorder).
Meeting DSM-IV criteria for dependence on any substance other than cocaine and nicotine.
Significant underlying medical or psychiatric conditions or hypersensitivity to modafinil that in the opinion of the PI would interfere with study participation.
Abstinence from cocaine for more than one week prior to inpatient admission.
Positive urine or serum pregnancy test.
Women who are pregnant or lactating, or not using a reliable method of birth control.
(For subjects completing the fMRI portion of the study) Presence of or history indicative of ferromagnetic metal in their bodies.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582491

Contacts

Contact: Peter Morgan, MD, PhD	203-974-7515	peter.morgan@yale.edu
Contact: Andrea Rodrigues, BS	203-974-7491	andrea.rodrigues@yale.edu

Locations

United States, Connecticut
Connecticut Mental Health Center	Recruiting
New Haven, Connecticut, United States, 06519

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Peter T Morgan, MD, PhD

Yale University

More Information

Responsible Party:	Yale University School of Medicine ( Robert Malison, MD )
Study ID Numbers:	0607001659, R01DA11744
Study First Received:	December 21, 2007
Last Updated:	December 27, 2007
ClinicalTrials.gov Identifier:	NCT00582491
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

Modafinil
Sleep
Cognition
Cocaine Dependence

Study placed in the following topic categories:

Cocaine-Related Disorders
Sleep Disorders
Disorders of Environmental Origin
Cognition Disorders
Modafinil
Signs and Symptoms
Dopamine

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Substance-Related Disorders
Neurologic Manifestations
Dementia
Cocaine
Delirium

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Central Nervous System Stimulants
Cardiovascular Agents

Protective Agents
Neuroprotective Agents
Anesthetics, Local
Pharmacologic Actions
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009